Actively Recruiting
The EMIRATES Study
Led by Royal Marsden NHS Foundation Trust · Updated on 2025-03-21
15
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
R
Royal Marsden NHS Foundation Trust
Lead Sponsor
W
Wrightington, Wigan and Leigh NHS Foundation Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
This pilot study will take place in thyroid outpatient clinics. It will have two study arms running in consecutive order: first, a Control arm where standard care will take place without PDA-TC, then a Patient Decision Aid (PDA) arm where the PDA-TC is implemented into the clinical practice. Within each arm, eligible patients will attend two thyroid cancer outpatient clinical consultations during which the patient will make a shared decision with their clinicians regarding surgical treatment between hemithyroidectomy and total thyroidectomy. In the PDA arm, the PDA TC pamphlet will be introduced to study participants after the initial clinical consultation. The participants will be encouraged to read and digest information related to the disease and treatment options on PDA-TC before returning for their second consultation where a treatment decision will be made together with their clinicians. Participants will be asked to complete the Decisional Conflict Scale questionnaire after each consultation in both study arms. The patient will also complete a Satisfaction with Decision Scale questionnaire and a Preparation for Decision Making Scale questionnaire after the second consultation in both arms.
CONDITIONS
Official Title
The EMIRATES Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Aged over 18
-
Both genders
-
Patients who are diagnosed of low-risk well-differentiated thyroid carcinoma (papillary thyroid carcinoma or follicular carcinoma) with size of 1-4cm. This is either:
- Diagnosed pre-operatively by fine-needle aspiration cytology (FNAC) with Thy5 grade [see appendix for the Thy classification] or
- Confirmed following diagnostic hemithyroidectomy
-
Able to communicate in spoken and written English
You will not qualify if you...
- Patients who are diagnosed with thyroid cancer with adverse features (i.e. poor differentiated cytology or tall cell, columnar cell, Hurthle cell, and solid variant cytology)
- Patients who are diagnosed with thyroid cancer which is multifocal, bilateral, with extrathyroidal extension, with perineural invasion or angioinvasion.
- Patients who are diagnosed with thyroid cancer with clinically or radiologically involved nodes or distant metastases
- Patients who are diagnosed with thyroid cancer which is of a familial disease
- Patient who is either Pregnant or breast-feeding
- Patient with hyper- or hypothyroidism who is a candidate for surgery
- Patient who is concurrently diagnosed with any medullary, anaplastic, lymphoma, or parathyroid disease
- Patients who had previous thyroidectomy for reasons other than diagnostic hemithyroidectomy for their recent cancer diagnosis.
- Patients who are cognitively impaired or have a mental health condition and are therefore unable to give consent
- Patient who is not able to read write and speak English
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust
Wigan, United Kingdom
Actively Recruiting
Research Team
W
Wanding Yang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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